BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ANZAI MEDICAL CO, LTD.

    Reg #: 8031557 · FEI: 3008328959 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ANZAI MEDICAL CO, LTD.
    Registration Number
    8031557
    FEI Number
    3008328959
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2-6-9 OHSAKI
    City
    SHINAGAWA-KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K160432

    Owner / Operator

    Firm Name
    ANZAI MEDICAL CO, LTD.
    Operator Number
    8031557
    Address
    3-9-15 NISHI-SHINAGAWA, SHINAGAWA-KU
    City
    TOKYO
    State
    JP-NOTA
    Postal Code
    141-0033
    Country
    JP
    Correspondent
    Masako - Kobayashi

    US Agent

    Business Name
    C3-Carey Consultants, LLC
    Contact Name
    Carole C Carey
    Address
    9451 Ellsworth Ct
    City
    Fulton
    State
    MD
    ZIP
    20759
    Country
    US
    Email
    [email protected]
    Phone
    301 3952249

    Products

    Device Name Product Code
    System, Radiation Therapy, Charged-Particle, Medical LHN
    Synchronizer, Ecg / Respirator, Radiographic IXO
    Instrument, Quality-Assurance, Radiologic LHO

    Proprietary Names

    AZ-733VI Respiratory Gating System AZ-733V & AZ-733VI AZ-M1PP Motion Phantom Platform AZ-M2PP Motion Phantom Platform

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device